Miniature ingestible capsule

ABSTRACT

A miniature ingestible capsule has multiple therapeutic or diagnostic operations that can be performed. These functions are controlled by a combination of an outside control, a pose beacon and through information relayed from an imagining array and transmitter. These functions can be in a separate capsule without an imaging array or within the same capsule with an imaging array. Typically, there is one function performed in addition to imaging. These functions can include suction and spray capabilities, ultrasound sensor, lithotripsy, laser, heat, electrocautery, BICAP, biopsy forceps, a needle knife snare cautery (cold and hot with continuous or pulsed current for cutting and coagulation), with a basket, and fine needle aspiration with various wheels and fins and motors controlled externally and other tools to be used in humans. All of these tools can be attached to a retractable arm. Also, they can be used on an elevator device that lifts them, allowing for an extra 180° of movement.

CLAIM OF PRIORITY

This application claims priority to and the benefit of U.S. ProvisionalApplication Ser. No. 61/110,316, filed on Oct. 31, 2008.

FIELD OF THE DISCLOSURE

This disclosure relates to a miniature ingestible capsule for imagingthe gastrointestinal tract for medical diagnosis or diagnosis and/ortherapy for the human body. More specifically, this invention relates tononinvasive, noninterventional methods for internal examination of thegastrointestinal tract or other internal therapy and diagnosis of thehuman body that are significantly more convenient, comfortable, lower incost and more advanced compared with current invasive diagnostic methodssuch as colonoscopy, sigmoidoscopy, esophagogastroduodenoscopy and pushenteroscopy.

BACKGROUND OF THE DISCLOSURE

The mammalian gastrointestinal tract comprises the esophagus, stomach,small intestine, and colon. Physicians image the interior of thegastrointestinal tract to aid in the diagnosis and treatment of manyillnesses such as ulcers, growths, cancers and bleeding spots. Morespecifically, these conditions include colorectal cancer, colonicpolyposis, inflammatory bowel disease, irritable bowel syndrome,Barrett's esophagus, peptic ulcer disease and dyspepsia.

Colorectal cancer, for example, is the second leading cause of cancerdeath in the United States, with 133,500 new cases detected in 1996,54,900 (41%) of which resulted in death. (Agency for Health Care Policy& Research (AHCPR) Research Activities 200:15-16, 1997.) Survival ratesimprove and treatment costs decline with early detection of the process.(Brown, M. L. and Fintov, L. The economic burden of cancer. InGreenwald, P. Kramer, B. S., and Weed, D. L., eds Cancer Prevention andControl. New York, Marcel Decker, pp. 69-81, 1995. Healthy People 2000:Nutritional Health Promotion and Disease Prevention Objectives. U.S.Department of Health and Human Services, Public Health Service, DHHSPublication No. (PHS) 91-50212, p. 423, 1991.) However, regularscreening for colorectal cancer is not performed for the vast majorityof the populace due to the high cost of such programs and, moreimportantly, the reluctance of a healthy population at risk to undergoan invasive procedure again and again for surveillance against cancer.As a result, over two-thirds of patients are diagnosed with advanceddisease. (Eddy, D. M. Screening of colorectal cancer Ann. Int. Med.113:373, 1990).

The only low-cost noninvasive screening tests for colorectal cancer arefecal occult blood tests, which look for the presence of fecal occultblood in stool specimens. These tests exhibit poor sensitivity due tothe fact that malignant growths of the colon have to be fairly largebefore they start to bleed. Furthermore, there are many other reasonsfor bleeding into the gastrointestinal tract (e.g., ulcers) which leadto low specificity of the test and a high probability of falsepositives. (Eisner, M. S., and Lewis, J. A. Diagnostic yield of positiveFOBT found on digital rectal examination. Arch. Int. Med. 151:3180,1991. Rockey, D. C., Koch, J., Cello, J. P., Sanders, L. L., McQuaid, K.Relative Frequency of Upper Gastrointestinal and Colonic Lesions inPatients with Positive Fecal Occult-Blood Tests.) Even with the poorcharacteristics of fecal occult blood tests, the American Cancer Societyestimated that the regular use of the test in men over age 50 couldproduce a 15% reduction in mortality. (Agency for Health Care Policy &Research (AHCPR) Research Activities 200:15-16, 1997.)

The most common diagnostic procedure for colonic examination iscolonoscopy. This procedure involves the optical examination of theentire colon using a device known as a colonoscope. A colonoscopecomprises a flexible tube containing a fiber optic imaging andilluminating device and a device to resect portions of the surface ofthe intestinal tract. The colonoscope is inserted into the rectum andcan be maneuvered to the ileo-cecal junction (the start of the colon).The operator views the image on a video display. The medical teamperforming this procedure usually comprises a gastroenterologist,specially trained nurses and at times an anesthesiologist. Polyps(tumors) are identified visually and biopsied. If examination of thespecimen reveals malignancy, a surgical team resects the regionscontaining the tumors. Usually, this is followed by a period ofchemotherapy, administered to fight unobserved or secondary tumors;annual colonoscopies may be prescribed. Considering the cost of thecolonoscopy alone, a yearly colonoscopy for all patients over age 48 forinstance, would be prohibitively expensive. Colonoscopy for asymptomaticpatients is seldom prescribed.

The sigmoidoscope is similar to a colonoscope, but can only be used toimage the lower ⅔ of the colon. Although simpler than a colonoscope, itsoperation still requires the presence of a highly trained physician andoften requires sedation.

The esophagogastroduodenoscope is used to image the uppergastrointestinal tract, namely, the esophagus, the stomach and theduodenum. It is inserted through the mouth. Again, its operationrequires the presence of a highly trained physician and often requiressedation.

The esophagogastroduodenoscope is used to identify ulcers, gastritis,AVMs, esophagitis, varices, duodenitis, Barrett's esophagus, hiatalhernias and tumors. The esophagogastroduodenoscope procedure isperformed on patients with a variety of symptoms that include nausea,vomiting, abdominal bloating, abdominal pain, heartburn, reflux, familyhistory of cancer, jaundice, weight loss, anemia, and gastrointestinalbleeding. A majority of those procedures are diagnostic. Considering thecost of endoscopy and the sedation requirement, it would beprohibitively expensive to perform esophagogastroduodenoscopy on allpatients with symptoms.

The push enteroscope is used to image the third and fourth portions ofthe duodenum and the proximal jejunum. It is inserted through the mouth.Its operation requires the presence of a highly trained physician andrequires sedation. The push enteroscope may be used to detectarteriovenous malformations and small intestinal tumors.

The endoscopic retrograde cholangiopancreatograph procedure is done tovisualize, to treat, and to diagnose pancreatic and biliary diseases.The endoscopic ultrasound and transesophageal ultrasound are used toimage the esophagus, adjacent mediastinal structures, lungs, pancreas,aorta and other vessels, colon and heart. These techniques allow fortissue aspiration through a fine needle. Each of these proceduresinvolve the passage of and endoscope through the mouth. Their operationrequires the presence of a highly trained physician and a lot ofsedation.

The present invention is a type of non-tethered device that is ingestedby the patient, thereby passing through the entire gastrointestinaltract, sending images and data through a telemetry means. There areseveral prior systems that use an ingestible device to provide data onthe internal state of a patient. The Heidelberg capsule relays pHinformation through a radio frequency (RF) link, and can releasemedicament on a signal from an external transmitter. The Konigsbergcapsule monitors temperature and uses a RF link. The Cortemp pill, whichis commercially available at this time, also monitors the bodytemperature, but uses a near-field magnetic link.

More sophisticated approaches such as colonoscopy and relatedgastrointestinal imaging methods, namely, sigmoidoscopy andesophagogastroduodenoscopy, are more effective because they can identifyabnormalities before the occurrence of late-stage symptoms (e.g., bloodin the stools for colonic tumors or tarry stools for peptic ulcers).However, these methods see limited use for several reasons. One, theyare invasive and uncomfortable to the patient, requiring sedation sothat a flexible fiberoptic tube can be inserted into the tract. This isa major limitation of these tests in their application to healthyasymptomatic individuals for repeated examinations (every 1-3 years).

Secondly, these tests are expensive, requiring the presence of aphysician and other personnel. Third, they are inconvenient, requiringthe patient to take a purgative, fast overnight, and remainincapacitated during the procedure.

Thus, there is a medical and economic benefit for an inexpensive,noninvasive, miniature, ingestible imaging or diagnostic device thatallows the patient to use the device while still performing the normalactivities of daily living. Furthermore, it would eliminate the need forhighly trained personnel for its operation. In light of the high cost ofcurrent imaging methods (and their subsequent limited and late-stageapplication), hospitals, clinical laboratories, and Health ManagementOrganizations (HMOs), will be able to employ these devices as acost-containment strategy.

Accordingly, it has been considered desirable to develop a new andimproved miniature diagnostic and therapy device which would overcomethe foregoing difficulties and others and meet the above-stated needswhile providing better and more advantageous overall results.

BRIEF SUMMARY OF THE DISCLOSURE

The present disclosure relates to a miniature capsule. Moreparticularly, it relates to a miniature non-digestible capsule,ingestible by a human or other animal for performing internal diagnosticor therapeutic functions.

One embodiment of the capsule comprises an impermeable anterior andposterior membrane, a transparent window, an imaging device, a posebeacon, a transmitter, and a power supply, and an external unitcomprising a data reception device, a recording device, and a posedetection system. Ingested by a patient, the capsule will pass throughthe entire gastrointestinal tract of the patient, providing real-timecircumferential images of the esophagus, stomach, small intestine, andcolon, which can be viewed and recorded by the physician. The capsuleexits the patient through the rectum. The device can either be discardedor reused by replacing the membranes.

A miniature color imaging device, such as a CCD array and lens, and anillumination device, such as an RGB diode array or similar low-powerwhite light source provide real-time color images of thegastrointestinal tract. The image is transmitted in real-time by atransmitter, such as a miniaturized UHF video transmitter, to anexternal reception device, such as a television monitor and a recordingdevice, such as a video cassette recorder. The capsule may be weightedin such a way as to maintain a particular orientation in the stomach. Insimultaneous operation with the imaging system is a sixdegree-of-freedom pose detection device that calculates the real-timepose of the capsule, thus tracking the device through patient's bodyrelative to a fixed external reference frame that may be strapped to thepatient's abdomen.

In one arrangement, this device is a passive beacon which is tracked byan external detector strapped to the patient's body, which relays posedata that is correlated with received video data by a computer.Alternatively, the pose detector may be an active device whose data iseither multiplexed with the image data prior to transmission or is senton a second channel of the telemetry device. An electric power sourcesuch as a lithium battery provides sufficient energy to power all thecomponent devices for a time period of at least 72 hours, the maximumtransit time for the gastrointestinal tract. (The average transit timeis 48 hours, with a range of 24 to 72 hours.)

The pose detector is not absolutely necessary for the successful use ofthis device. A trained physician will likely be able to infer theapproximate location of a given image from its appearance and the timeit is recorded (since the range of transit times through the parts ofthe tract are well documented).

In another form, the capsule includes a reception capability, such as aradio-frequency receiver, and an internal microprocessor that allowsinstructions to be relayed from the physician to the capsule. Miniaturemotors allow the imaging system to be reoriented, or provide some formof “controlled mobility,” which could include a remote control,joystick, mouse control or other computer-directed or voice-directedcontrol or other control. An expandable bladder attached to the capsulecan be expanded to stabilize the capsule or slow its motion through thetract. The system may also include on-board signal processing circuitryto automatically stabilize the image. Alternatively, a micro-machinedmechanical stabilization platform can be built into the imaging system.The imaging system may also include a means such as a prism orfiber-optic device, to direct multiple images onto the imaging device.

In an alternate embodiment, a capsule would comprise an anteriormembrane with a port for an ultrasound sensor, a transmitter, a posebeacon, a power source, and a posterior membrane. The capsule would notinclude an imaging device or lens.

The anterior membrane is made of a non-allergenic, nondigestible,impervious material. The port is curved to match the curvature of anoutside surface of the anterior membrane. The posterior membrane is alsomade of a non-allergenic nondigestible impervious material, and mayinclude an integrated antenna for the transmitter.

Other forms of the capsule have the capacity for specialized toolsincluding biopsy forceps and snares (with cold and hot snares withcoagulation and cutting current) for purposes like polypectomy andbaskets for retrieval and rat tooth forceps for retrieval and for otherminiature specialized devices. The operation of these devices iscontrolled in a similar fashion to the position of the capsule. Localmucosal resection can be performed in one embodiment with a combinationof hot snare cautery and suction. Furthermore, another form hastreatment tools using, for example, heat and electro cautery current,BICAP current, argon plasma coagulation and laser current. All thesecurrents can be continuous or time pulsed in cutting or coagulationmodes. Each of these embodiments mentioned above can be designed withthe imaging apparatus or without the imaging apparatus.

These tools can be connected to an elevator device within the capsuleallowing an extra range of movement of 180° for the tools.

One aspect of the present disclosure is the provision of a method forimaging a gastrointestinal tract that uses an ingestible device thatallows a patient to use the device while still performing normalactivities of daily living.

Another aspect of the present disclosure is that it would eliminate theneed for highly trained personnel for its operation.

Yet another aspect of the present disclosure is that it is economicallyaffordable and less expensive than existing methods of imaginggastrointestinal tracts.

Still another aspect of the present disclosure is that it is easier toimplement and allows patients to be examined more frequently thanexisting methods of imaging gastrointestinal tracks.

Another aspect of the disclosure is a supraconductor filter.

Another aspect of the disclosure is a stent.

Another aspect of the device is an opening or a needle for injectingdrugs or substances, into an artery.

Another aspect of the disclosure is the application of sutures tointernal organs.

Still other functions and benefits of an embodiment of the disclosureinclude the ability to provide ultrasound imaging with a miniatureultrasound sensor and to image and treat problems with the pancreaticand biliary ducts and gastrointestinal system and the rest of the humanbody. In another embodiment, with a special dye injection port forvarious dyes imaging of, for example, the biliary and pancreatic ductsand the rest of the human body can be done. Treatment apparatus portsallow for cutting and coagulation currents to be delivered locally.

Furthermore, a focal laser treatment, argon plasma coagulator treatment,lithotripsy treatment with ultrasound current can be used in the biliaryand pancreatic ducts, gastrointestinal system and rest of human body inother forms of the invention. In addition, tools including miniaturebaskets, miniature snares, miniature needles with epinephrine (forexample) and other treatments, miniature forceps, miniature cytologybrushes can be included in a form of the capsule for diagnosis andtreatment in the biliary and pancreatic trees, pancreas, liver, andgastrointestinal system, and human body. Also, a thin wire, catheter,miniature plastic or metal stint can be deployed in the biliary andpancreatic ducts in other forms of the capsule. Finally, the capsule hassuction capabilities to remove unwanted debris and can sprinkle waterand n-acetyl cysteine locally over the lens or capsule to removeresidual debris from the gastrointestinal system to improve or enhancevisualization, diagnostic, therapeutic or other functions of thecapsule.

Still other benefits and advantages of the present disclosure willbecome apparent to those skilled in the art upon a reading andunderstanding of the following detailed specification.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may take form in certain parts and arrangements of parts,embodiments of which will be described in detail in this specificationand illustrated in the accompanying drawings which form a part hereofand wherein:

FIG. 1 is a diagram showing the main components and signal flow for theimaging system;

FIG. 2 is an exploded view of the capsule in accordance with the firstembodiment of the present invention;

FIG. 3A is a perspective view of the capsule with an internal lens and atransparent window in the membrane in accordance with the firstembodiment of the present invention;

FIG. 3B is a sectional view of the capsule of FIG. 3A;

FIG. 4A is a perspective view of the capsule with an external lens inaccordance with a second embodiment of the present invention;

FIG. 4B is a sectional view of the capsule with an external lens of FIG.4A;

FIG. 5A is a perspective view of a capsule with an internal lens and aflat transparent window in the membrane in accordance with a thirdembodiment of the present invention;

FIG. 5B is a sectional view of the capsule of FIG. 5A;

FIG. 6 is a perspective view of a capsule with wheels in accordance witha fourth embodiment of the present invention;

FIG. 7 is a perspective view of a capsule with fins in accordance with afifth embodiment of the present invention;

FIG. 8 is a perspective view of a capsule with prongs on a posteriormembrane of the capsule in accordance with a sixth embodiment of thepresent invention;

FIG. 9 is a perspective view of a capsule with a port and a treatmenttool in accordance with a seventh embodiment of the present invention;

FIG. 10 is a perspective view of a capsule with a treatment tool such asextendable biopsy forceps or extendable basket, retractable basket,retractable rat tooth forceps, retractable cytelogy brush, retractablesnares or other miniature devices for diagnosis and therapy in the humanbody in accordance with an eighth embodiment of the present invention;

FIG. 11 is a perspective view of a capsule with a treatment tool such asa retractable needle or retractable catheter for injection or retrievalin accordance with a ninth embodiment of the present invention;

FIG. 12 is a perspective view of a capsule with a suction port andsuction tube in accordance with a tenth embodiment of the presentinvention;

FIG. 13 is a perspective view of a capsule with a rotating lens andwiper in accordance with an eleventh embodiment of the presentinvention;

FIG. 14A is a perspective view of a capsule with an ultrasound sensorport in accordance with a twelfth embodiment of the present invention;and

FIG. 14B is an exploded, perspective view of the capsule of FIG. 14A.

FIG. 15 is an exploded view of a capsule with a miniature supraconductorfilter is accordance with another aspect of the disclosure;

FIG. 16 illustrates HTS strips used with the filter of FIG. 15;

FIG. 17 illustrates a cryogenic chamber surrounding HTS strips of FIG.16;

FIG. 18 is a diagram illustrating a capsule in an artery for visualizingplaque;

FIG. 19 is an illustration of a wireless capsule in an artery with aclot;

FIG. 20 is an illustration of a wireless capsule in a pancreas to detecta cancer mass;

FIG. 21 is a perspective view of a capsule with a stent;

FIG. 22 is a capsule with a tool for injecting drugs;

FIG. 23 is a perspective view of a capsule with a laser in catheter;

FIG. 24 is an illustration for a capsule within a human body;

FIG. 25 illustrates a capsule suturing a gallbladder; and

FIG. 26 illustrates a pair of therapeutic and diagnostic capsules.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring to the drawings, wherein the showings are for purposes ofillustrating preferred embodiments of this disclosure only, and not forpurposes of limiting same, FIG. 1 shows a block diagram for the device.An illuminator 10 inside the capsule 12 projects light into thegastrointestinal tract. Images enter the capsule through a lens 14,impinging on an imaging array 16, the signal from which is thentransmitted by a transceiver 18 to a transceiver 20 outside of thecapsule. A power source 22 inside the capsule provides power to theimaging array 16, transceiver 18, and illuminator 10. The data from thetransceiver 18 is then relayed to a recording and display device 24.Simultaneously, a pose detection system 26 tracks a beacon 28 locatedinside the capsule and relays tracking information to the recording anddisplay system 24, which forms a display 30.

There are several external components to the external station 32. Thebasic system only requires the transceiver 20 to capture the imageinformation. A more complex design would include a transmitter in theexternal station and a receiver in the capsule, enabling the externalcontroller to transmit instructions to the capsule itself. The posedetection system 26 is a powered device that produces an RF signal or EMfield that allows the capsule's beacon to be tracked. The device can bestrapped to the patient's body. The pose data can be read by therecording and display device 24 and correlated with the image data. Therecording and display device 24 may be used to record and integrate theimage and pose data and data from other sources such as a CAT scan orMRI, and produce a display 30 for the physician.

Referring to FIG. 2 in accordance with the first preferred embodiment ofthe present disclosure, an imaging device A includes a capsule 40including an anterior membrane 42 through which images are viewed, alens 44 positioned within the membrane, an illumination device 46(comprising a light source and projection device) positioned adjacent tothe lens, an imaging array 48, transmitter 50, a pose beacon 52, a powersource 54, and a posterior membrane 60.

The anterior capsule membrane 42 is made of a non-allergenic,nondigestible, impervious material with at least one transparent windowor opening 62 for the lens 44. The window 62 is curved to match thecurvature of an outside surface of the anterior membrane 42. Theposterior membrane 60 is also made of a non-allergenic nondigestibleimpervious material, and may include an integrated antenna (not shown)for the transmitter.

FIGS. 3A and 3B show the capsule 40 in the assembled configuration. Thetransparent window 62 is made of a material to which mucous and otherbiological materials will not adhere. An additional advantage of aninternal lens design is that the lens can be mounted at an optimaldistance to maintain focus.

The lens 44 may be mounted behind the transparent window 62 in thecapsule, or it may be mounted in an opening in the capsule so that itsfront surface is exposed to the outside. The lens 44 may be a plastic orglass lens, a prism or a fiber optic bundle. One advantage of a fiberoptic bundle is that its front end can be designed to image severalviews of the external environment, thus producing a composite image onthe array plane. The focal length of the imaging system must be smallenough to achieve infinite focus at approximately 1 mm.

The simplest and most cost effective imaging array 48 is a CCD(charge-coupled device) array. It may be necessary to provide shieldingfor the CCD array to prevent RF interference from the transmitter. Aslightly oversized CCD array plus digital signal processor (DSP)circuitry can be included to allow real-time stabilization of the image,by time-correlating a series of images from the oversized array toilluminate image blur and shake electronically. New micromachiningtechnologies may be included in the array itself to provide imagestabilization. These devices would essentially incorporate a passive oractive damping system into the CCD chip itself. To maximize space foradditional circuitry such as a DSP for on-board image processing, signalmultiplexing and signal encoding can be constructed on flexible circuitboard that can wrap circumferentially around the inside of the capsule.

The type of illuminating device or light source 46 depends to a certainextent on the choice of imaging array. The use of a low-lux imagingarray obviates the need for a high-power light source. The source shouldapproximate a white light source so that a color image can be obtained.Methods for producing a white light source at very low power include3-diode light source, inorganic LEDs, and full-color organicelectroluminescent sources. FIG. 2 shows a light source 46 which istoroidally shaped and backed by a ring-semi-parabolic mirror, concentricwith the window 62 and lens 44.

The pose beacon 52 provides a useful auxiliary piece of information, thereal-time position of the capsule relative to the patient's body. Thisinformation will eliminate the discomfort of a tether or the guessworknecessary in pinpointing the location of abnormality by simple visualexamination of the video or by time-tracking the video. There currentlyexist several proven methods to determine the six degree-of-freedom poseof a remote object, most often used in robotics to track mobile robotsor to digitize human movements, for example, in hand-tracking andhead-tracking controllers. These devices use a RF or EM beacon thatreflects signals from an externally fixed transmitter, somewhat like aminiature radar system. Distances are typically limited to a few meterscubic, which fall well within the specifications for this device. Thebeacons are passive devices and will not draw power from the onboardbattery. External stations that can be strapped or belted to the patientprovide the signal sources. Given the recorded time-spacing trackinginformation, there are numerous ways to develop a correspondence betweenthe video images and the patient's internal structures. For example, acomputer can overlay the time-parametrized space-path of the capsule onan image based on CAT scan or MRI of the patient, or over acomputer-generated model based on the patient's body size and shape. Thevideo can then be synchronized with the capsule's motion on the computerscreen.

The capsule requires a transmitter 50 rather than a transceiver. Thesimplest approach is to use a miniature amplitude modulation (AM) videotransmitter in the 400 MHz-1.5 GHz region. Other standard transmissionmethods include frequency modulation (FM), pulse-code modulation (PCM),and frequency shift keying (FSK). For more complex arrangements, anon-board receiver will allow the base station to communicate with thecapsule.

The power source 54, is a device of relatively high energy density,capable of 10's of mA in the 0.5-9V range (these numbers are for thecurrent commercially available CCD and RF devices). The power source 54must fit within approximately ½ the volume of the capsule, approximately⅓ cc, and must run the device for 72 hours at the body temperature(approximately 37° C.). Additionally, the nature of the imager willdetermine the amount of light necessary to provide the desired imagequality.

Off-the-shelf ⅓″ CCD board-cameras have power requirements in the rangeof 50-200 mA at 9VDC. However, a portion of this requirement is for theline driver, which enables the output signal to be sent on a longcoaxial cable (e.g., 60′ plus). Since a line driver is not a requirementfor this device, we can expect a much lower current requirement.Off-the-shelf video transmitters require approximately 50 mA current at9V. These devices, however, transmit signals at a design distance of100-500′.

The power source or battery 54 may also be designed to act as theballast to orient the capsule in the stomach. In other words, thebattery will be situated to the posterior of the capsule.

There are several lithium battery types currently used in implantablebiomedical applications. One type is lithium iodine. These are currentlyused in implantable cardiac pacemakers; microamp range over longperiods, a 4 mm thick 10 mm radius disc has an energy volume of 400mA-hrs. Lithium Silver Vanadium Oxide batteries are used in both highamperage applications (e.g., defibrillator) and medium amperageapplications (e.g., neurostimulators) and have a current of 50 mAcontinuous. Lithium Carbon Monofluoride batteries are used in mediumamperage applications such as neurostimulators and drug infusion pumps.

The battery 54 will include some form of integrated on-off switch forthe capsule, activated, for example, by twisting the posterior capsulewith respect to the anterior capsule, or similar method that will not beaccidentally actuated by peristalsis of the gut.

Referring now to FIGS. 4A and 4B, an imaging device B includes a capsule70 with an external lens 72 in accordance with a second preferredembodiment of the present disclosure is shown. The front surface of thelens is exposed to the external environment. The lens 72 is positionedon an outside surface of an anterior membrane 74 of the capsule. Thisembodiment does not have a window. As discussed above, the capsulefurther includes an illumination device 76, an imaging array (notshown), a transmitter 78, a pose beacon 80, a power source 82, and aposterior membrane 84. In case the desired lens material is not idealfor limiting fluid adherence, such that fluids may build up on itssurface and reduce image quality, a transparent window may be used.

Referring now to FIGS. 5A and 5B, an imaging device C includes a capsule100 in accordance with a third preferred embodiment of the presentdisclosure is shown. The capsule 100 has an internal lens 102 and a flattransparent window 110 in the membrane.

The capsule further includes an illumination device 114, an imagingarray (not shown), a transmitter 116, a pose beacon 118, a power source120, and a posterior membrane 122.

Referring now to FIG. 6, wheels 140 may be added to the capsule 150 inaccordance with a fourth embodiment of the present disclosure. Thecapsule may be one of the three embodiments previously described. Thewheels would be powered by a remote control device (not shown). Thewheels 140 would have spokes 142 which would provide friction and enablethe wheels to move along surfaces. The capsule with wheels would be usedprimarily for situations where the stomach is virtually dry, not fluidfilled; such as a result of the patient fasting. Two sets of four wheels140 equally spaced may be placed around the circumference of thecapsule. Also, the capsule with wheels may be used in addition to asecond capsule. The capsule with wheels may provide a therapeuticfunction instead of a diagnostic function. That is, the capsule maysupply medicine or perform another therapeutic function to the areabeing investigated by the second capsule. One capsule would not be ableto detect the area being investigated through a video system as well asprovide medicine or other therapeutic relief.

In the situation where the stomach is at least partially fluid-filled,fins 160 in lieu of wheels may be placed on the exterior surface ofcapsule 170 as illustrated in a fifth embodiment in FIG. 7. The fins 160would aid the capsule in moving throughout the stomach.

In a sixth embodiment, referring to FIG. 8, prongs 180 would extend fromposterior end 182 of capsule 184. The prongs 180 can be retractable andwould serve as a base for the capsule to effectively anchor or stabilizethe capsule. A laser or biopsy forceps (not shown) could extend from theanterior portion 186 of the capsule.

In a seventh embodiment, referring to FIG. 9, a port 200 is provided incapsule 201 with an opening for a treatment tool 202, such as a laser orultrasound sensor. Alternatively, the treatment tool 202 can be an argonplasma coagulator, BICAP or a dye injection device or a heat cautery.

Treatment tool 202 can include heat and electro cautery current, BICAPcurrent, argon plasm coagulation or laser current. All these currentscan be continuous or time pulsed in cutting or coagulation modes.

Ultrasound scanning or ultrasonography is a technique to image humantissue. By definition, ultrasound is a sound wave having a frequencygreater than 20 khz. The sound waves used in ultrasonography areproduced form a device called a transducer. Arrays of ultrasonic wavesscan tissue and are reflected back to the transducer.

Still other functions and benefits of an embodiment of the disclosureinclude the ability to provide ultrasound imaging with a miniatureultrasound sensor and to image and treat problems with the pancreaticand biliary ducts and gastrointestinal system and the rest of the humanbody. In another embodiment, with a special dye injection port forvarious dyes imaging of, for example, the biliary and pancreatic ductsand the rest of the human body can be done. Treatment apparatus portsallow for cutting and coagulation currents to be delivered locally.

Furthermore, treatment tool 202 can include a focal laser treatment,argon plasma coagulator treatment, or lithotripsy treatment withultrasound current which can be used in the biliary and pancreaticducts, gastrointestinal system and rest of human body in other forms ofthe disclosure.

In an eighth embodiment (FIG. 10), a treatment tool 300 is added to aport in the front portion of the capsule 302. A retractable lever 304protrudes from the capsule exposing the tool 300. Upon completion of thetreatment operation, the tool may be retracted within the capsule.

The specialized tool 300 can include biopsy forceps or retractablesnares (with cold and hot snares with coagulation and cutting current)for purposes like polypectomy. Alternatively, tool 300 can include anextendable basket, retractable basket, retractable rat tooth forceps,retractable cytology brush, which can be used for diagnosis and therapyin the human body. Miniature snares, miniature needles with epinephrine(for example) and other treatments, miniature forceps, miniaturecytology brushes can be included in a form of the capsule for diagnosisand treatment in the biliary and pancreatic trees, pancreas, liver, andgastrointestinal system, and human body. The operation of these devicesis controlled in a similar fashion to the position of the capsule. Localmucosal resection can be performed in one embodiment with a combinationof hot snare cautery and suction. Each of these embodiments mentionedabove can be designed with the imaging apparatus or without the imagingapparatus.

In a ninth embodiment (FIG. 11), a treatment tool 400 for injection orretrieval (such as a needle or catheter) would be added to capsule 402.The tool 400 would be retractable into the capsule. A needle would be asclerotherapy needle to sclerose a dilated vein. Alternatively, theneedle could provide epinephrine to a bleeding vessel to stop bleeding.Also, tool 400 can include a thin wire, catheter, or a miniature plasticor metal stent can be deployed in the biliary and pancreatic ducts inother forms of the capsule.

In a tenth embodiment (FIG. 12), a suction port 500 is provided incapsule 502. The suction port 500 would pass through the capsule fromanterior portion 504 to posterior portion 506 of the capsule. Fluid isthen suctioned through a suction tube 508 through the suction port ofthe capsule. The capsule would have suction capabilities to removeunwanted debris and can sprinkle water and n-acetyl cysteine locallyover the lens or capsule to remove residual debris from thegastrointestinal system to improve or enhance visualization, diagnostic,therapeutic or other functions of the capsule.

In an eleventh embodiment referring to FIG. 13, a rotating lens 600 forcapsule 602 is provided which rotates on an axis (not shown). The lenscontains a small amount of liquid (such as alcohol with n-acetylcysteineor water) to clean the surface of the lens with a rotating wiper 610.The wiper rotates on the same axis as the lens.

Referring to FIGS. 14A and 14B, in a twelfth embodiment, a capsule 700would comprise an anterior membrane 702 with a port 704 for anultrasound sensor 706, a transmitter 708, a pose beacon 710, a powersource 712, and a posterior membrane 714. The capsule would not includean imaging device or lens.

The anterior membrane 702 is made of a non-allergenic, nondigestible,impervious material. The port 704 is curved to match the curvature of anoutside surface of the anterior membrane. The posterior membrane 714 isalso made of a non-allergenic nondigestible impervious material, and mayinclude an integrated antenna (not shown) for the transmitter.Embodiments illustrated in FIGS. 6-13 and discussed above can also beincorporated into capsule 700.

Each of the treatment tools 202, 300 and 400 can be connected to anelevator device (not shown) which is used to elevate or lift the treatedtools through different angles with a remote control device adding anadditional 180° of range of movement.

Each capsule can include a reception capability, such as aradio-frequency receiver, and an internal microprocessor that allowsinstructions to be relayed from the physician to the capsule. Miniaturemotors allow the imaging system to be reoriented, or provide some formof “controlled mobility,” which could include a remote control,joystick, mouse control or other computer-directed or voice-directedcontrol or other control (not shown). An expandable bladder attached tothe capsule can be expanded to stabilize the capsule or slow its motionthrough the tract. The system may also include on-board signalprocessing circuitry to automatically stabilize the image.Alternatively, a micro-machined mechanical stabilization platform can bebuilt into the imaging system. The imaging system may also include ameans such as a prism or fiber-optic device, to direct multiple imagesonto the imaging device.

In accordance with another aspect of the disclosure, to enhance theenergy capacity of the capsule endoscope the use of supraconductivitywill be essential in years to come. This will be able to drive downcosts and increase usage, allowing the most people to use thistechnology.

Specifically, thin-film supraconducting filters 800 combined withcryogenically cooled, low noise semiconductor amplifies in base stationsfor the capsule endoscope monitoring can provide increased diagnosticand therapeutic capacities of each individual wireless capsule endoscopeand permit greater monitoring to occur from remote areas (i.e., rangeand distance) and in areas with larger population of patients undergoingsimilar testing (i.e., higher quantities simultaneously).

The thin supraconducting filters can be in different forms. In FIG. 15,a representative supraconducting filter 800 is shown. The filter can beplaced anywhere along the length of the capsule. This particular filteris typical for a wireless base station. Its size is 18 mm by 34 mm andhas 10 folded high temperature superconductors (HTS) strips 802 (FIG.16). This needs to be in or surrounded by a cryogenic cooled, low noisesupraconductor amplifiers 804 (FIG. 17). These lie in between theparticular activities of the base station. In FIG. 17, there areantennae 805 on one side that receive signal from the wireless capsuleendoscope. They then transmit to a base station receiver 806 as shown inFIG. 17.

Similarly, any other function can be received and transmitted for avariety of applications.

The miniaturized HTS stations 804 are depicted in nano and pico andsmaller sizes. These nano, pico, and smaller HTS stations form the basisfor higher energy capabilities of the wireless capsule endoscope. Thesmaller sized HTS station can be used to increase dramatically thecapabilities of illumination (of the light source and projectiondevice), the imaging array, transmitter, pose beacon and/or powersource.

In addition, the dramatically increased energy within the wirelesscapsule endoscopy can be used to create the robotic and therapeuticaspect of the wireless capsule endoscope. With the increased energycapacity, the levers and wheels and fins and therapeutic arms can beeasily moved. In addition, the actual therapeutic functions can easilybe performed such as taking biopsies, clipping blood vessels,controlling bleeding, coring out lesions, removing a plaque, measuringtemperature, pH and motility among other tasks.

In addition, molecular profiling of a lesion by enhancing the view canbe done. With the increased energy, the optical systems can beimplemented that have a significantly increased magnification to a pointof all maximal microscopes and for detection of molecular tags that areonly definable with current microscopes. All of this can be performedwith increased energy capacities.

These HTS systems are highly selective in frequency and are low-noise.In addition, many different materials can be used to construct these HTSsystem filters. HTS materials can be fabricated with novel Josephsonjunctions like bicrystal, step-edge and many more that truly providegreater epitaxial growth in a condensed manner. In addition, the use ofcuprates can enhance electron correlations. Intrinsic Josephsonjunctions between copper-oxygen planes allow for voltage standards witha potential for tens of thousands of junctions in series. YBCO-NB ringsthat take advantage of d-wave symmetry create hundreds of thousands ofjunctions. In addition, there are many materials like arsenic and ironthat can be used as the HTS materials as well as others. Many materialsexist that can be used as HTS materials in this capsule technology toenhance the abilities of each individual capsule.

In accordance with another aspect of the present disclosure, thewireless capsule can be used in other systems within the human body fordiagnostic and therapeutic interventions. An example of this is thecirculatory system. Specifically, as depicted in FIG. 18, the wirelesscapsule can pass through the conventional access to the heart and beused to perform cardiac catheterization. The capsule 810 is placed inthe artery 812 for visualizing plaque similar to that done in cardiaccatheterization. The capsule is used in a therapeutic manner in theartery to destroy, remove and heal clots and the base of clots.Substance 814 can be injected to heal the arteries and focally destroyand remove clots. As the capsule can be miniaturized to any size (nano,pico and even further), a small enough wireless capsule can be made thatis controllable by an external source in a robotic manner. The capsulecan provide enhanced imaging of the coronary arteries by anyvisualization method including but not limited to ultrasound, directvision or injection of contrast. Referring to FIG. 19, a wirelesscapsule can scavenge and sense a clot 813 based on a trained “eye” ofthe wireless capsule without the need of contrast, eliminating the riskof the patient. The capsule removes clots and heals the arteries;similar to a vacuum. Referring to FIG. 20, a wireless capsule canpenetrate any organ and treat a lesion such as cancer mass as depictedin FIG. 20 in the pancreas 815. The wireless capsule can remove thecancer, deploy treatment and focally genetically engineer and repair thefocal defect causing the tumor.

Another aspect of the wireless capsule is the version that hastherapeutic functions that specifically can release and dilate a balloon818 up in size to perform wireless angioplasty in a roboticallycontrolled manner. In addition, referring to FIG. 21, another aspect ofthe capsule has a stent 820 deployed by a robotic arm in or expandablematerial that can be deployed to keep an artery open. In addition, FIG.22, a drug or substance can be released via a needle 830 in a focalmanner to help destroy existing plaque or for other functions such ascoronary or other arteries rebuilding in terms of muscle wall, lining orotherwise. In addition, FIG. 23, a laser or atherectomy device 840 canbe used to remove or carve out plaque. In addition, genetic engineeringcan be performed locally with or without stem cells to fix an area of anartery.

Similarly, any artery in the entire body can be repaired in such amanner. These will be controlled externally by the robotic controls.These capsules can then be maneuvered back out of the body whencompleted. In addition, biodegradable capsules can be made as well thatwill not need to be removed but can be used.

In accordance with another aspect of the present disclosure, referringto FIG. 24, a wireless capsule 850 can be used in a human body 860 thegenitourinary system to look inside the urethra and proximally to thebladder, urethra and into the kidney. They have all of the visualizationfunctions and the therapeutic functions such as any other capsule andcan take biopsies, sample urine, deploy stents, repair as above in thecirculatory system and destroy stones with lithotripsy. The wirelesscapsule can be inserted either via a laparoscope 862 or any orifice ofthe human body. The capsule can be in miniature form and enter throughthe skin or through orifices and eventually penetrate through organsinto cavities of interest like the abdomen, the brain, etc. The wirelesscapsules can perform precise surgeries with robotic control and with lowinfection rates, secondary to small incisions. In FIG. 25, the capsuleis performing precise surgery on the gallbladder. A suture 870 isapplied by the capsule 850 on the gall bladder 890 in arobotically-controlled manner. A laser-like incision is made in thecystic duct 872. After the suture is placed and the gall bladder issevered, a capsule is released and a method to carry the gall bladderout through an orifice is performed. The methods include sutures, forks,tentacles, suction, staples, etc.

In addition, a wireless capsule can be used in the female anatomy tovisualize and treat the cervix, vagina and uterus. PAP smears can bedone with this device along with all of the therapies above. Inaddition, cryogenic conization and colposopy can be performed.

In addition, the nasopharyngeal cavity and the pulmonary system can beexamined and treated accordingly.

In accordance with another aspect of the disclosure, wireless capsulescan be robotically made to enter the abdomen and thorax and performsurgery in the most minimally invasive manner. These capsules arerobotically controlled and have all the functions described above,including being able to apply staples, sutures, needle-cautery andcoagulation, suction and all other functions required for surgery of anyabdominal procedure including, but not limited to, cholecystectomy,appendectomy, colon cancer surgery, colectomy, ulcer surgery and lungbiopsy. The advantage of these miniature capsules robotically controlledis that they are small, sterile and leave the patient with minimalincision but the best precision, as they can truly get into a tightniche and operate locally.

Referring to FIG. 26, a pair of the capsules can be used simultaneouslytogether to perform therapeutic functions (capsule 900) and diagnosticfunctions (capsule 902).

The disclosure has been described with reference to a preferred initialembodiment. Obviously, alterations and modifications will occur toothers upon a reading and understanding of this specification. It isintended to include all such modifications and alternations insofar asthey come within the scope of the appended claims or the equivalentsthereof.

1. An imagine device comprising: a membrane defining an internal cavity and being provided with a window; a lens disposed in relation to said window; a light source disposed in relation to said lens for providing illumination to outside of said membrane through said window; an imaging array disposed in relation to said lens, wherein images from said lens impinge on said imaging array; and a transmitter disposed in relation said imaging array for transmitting a signal from said imaging array to an associated transmitter outside of said capsule, said lens, light source and projection device, imaging array, and transmitter being enclosed within said internal cavity.
 2. The imaging device of claim 1, further comprising a supraconductor filter disposed within said membrane of said device.
 3. The imaging device of claim 2, wherein said supraconductor filter comprises HTS strips.
 4. The imagine device of claim 3, wherein said HTs strips are enclosed within a cryogenic chamber.
 5. The imaging device of claim 4, further comprising an antennae that receives a signal from an endoscope.
 6. The imaging device of claim 5, further comprising a base station receiver for receiving transmissions from said filter.
 7. The imaging device of claim 1, wherein said device comprises a port comprising an opening for a stent deployed by said capsule.
 8. The imaging device of claim 1, wherein said device comprises a port comprising an opening for injecting substances into an artery.
 9. The imaging device of claim 1, where said device comprises a means for removing clots from arteries.
 10. The imaging device of claim 1, wherein said device comprises a port comprising an opening for a needle for injecting drugs.
 11. The imaging device of claim 1 wherein said device comprises a port comprising an opening for an atherectomy catheter.
 12. The imaging device of claim 1, wherein said device can apply sutures to an internal organ.
 13. The imaging device of claim 1, further comprising a second imaging device, wherein one of said imaging devices is used for therapeutic applications while the other device is used for diagnostic applications. 